Fermented Dairy Products and The Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— FerMetS  

Official title:

Matrix Characterization and Effects of Fermented Dairy Products on Liver Fat, Cardiometabolic Risk and Gut Microbiome in Males With Symptoms of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755530
• Other study ID #: B363
• Secondary ID: H-20059243
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted as a randomized controlled trial with four parallel arms including four dairy products. We will investigate the health effects of including yogurt in the diet through a 16-weeks intervention period among 100 volunteering males with symptoms of the metabolic syndrome. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male

• Age between 30-70 years

• BMI of 28-45 kg/m2

• Abdominal obesity (defined as waist circumference >102 cm)

• Provided voluntary written informed consent

Exclusion Criteria:

• Body weight changes +/- 5% in the past three months

• Any diet, allergy or intolerance which results in not being able to follow the study protocol

• Contraindications related to MRI (pacemaker, stent, magnitic metal in the body, claustrophobia, physiological diseases or a body weight >160 kg)

• History or diagnosis of diabetes

• History or diagnosis of heart, liver, gastrointestinal or kidney disease

• History or diagnosis of illness related to energy balance

• History or diagnosis of eating disorders

• Simultaneous blood donation for other purpose than this study (and one month before initiating the study)

• Simultaneous participation in other clinical intervention studies

• Any other condition that judged by the investgator may interfere with the adherence to the study protocol

Related Conditions & MeSH terms

• Metabolic Syndrome
• Overweight
• Overweight or Obesity
• Syndrome

Intervention

Dietary Supplement:
• Regular whole milk
400 g/day of regular whole milk
• Yogurt with live bacteria
400 g/day of yogurt with live bacteria
• Yogurt with inactivated bacteria
400 g/day of yogurt with inactivated bacteria
• Acidified whole milk
400 g/day of yogurt with acidified whole milk

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Nutrition, Exercise and Sports	Frederiksberg	DK

Sponsors (5)

Lead Sponsor	Collaborator
Faidon Magkos	Arla Food for Health, Mælkeafgiftsfonden, University of Aarhus, University of Copenhagen, Department of Biology

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolome	Measurement of metabolomic markers in blood, urine and feces	Change from week -4 to week 16
Other	Physical activity	Measured by International Physical Activity Questionnaire (IPAQ)	Change from week -4 to week 16
Other	Sleep quality	Measured by Pittsburg Sleep Quality Index (PSQI)	Change from week -4 to week 16
Other	Perceived stress	Measured by Perceived Stress Scale (PSS)	Change from week -4 to week 16
Other	Life quality	Measured by Physical and mental life quality, Short Form-36 (SF-36)	Change from week -4 to week 16
Other	The influence of initial glucose metabolism	Statistical investigation of the effect of initial glucose metabolism on liver fat	Change from week -4 to week 16
Other	The influence of initial gut microbiota	Statistical investigation of the effect of initial microbiota assessed by fecal sample on liver fat	Change from week -4 to week 16
Other	The influence of initial body composition	Statistical investigation of the effect of initial body composition assessed by DXA scan on liver fat	Change from week -4 to week 16
Primary	Liver fat	Measurements of liver fat by Magnetic Resonance Imaging	Change from Week 0 to week 16
Secondary	Cardiometabolic risk	Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions	Change from Week 0 to week 16
Secondary	Cardiometabolic risk	Measured by fasting ALAT	Change from Week 0 to week 16
Secondary	Cardiometabolic risk	Measured by fasting blood pressure (automatic device)	Change from Week 0 to week 16
Secondary	Gut microbiome	Measurments of microbiota (fecal spot samples)	Change from week -4 to week 16
Secondary	Glucose metabolism (fasting samples)	Measurements of fasting glucose, insulin, C-peptide, HbA1C	Change from Week 0 to week 16
Secondary	Glucose metabolism (5 hour oral glucose tolerance test)	Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test	Week 16 (5 hour test)
Secondary	Inflammation	Measurements of fasting CRP	Change from Week 0 to week 16
Secondary	Inflammation	Measurements of fasting IL-6	Change from Week 0 to week 16
Secondary	Inflammation	Measurements of fasting TNF-alfa	Change from Week 0 to week 16
Secondary	Body composition	Measurements of body weight (every week), height (stadiometer) (only at screening), waist and hip circumference (non-elastic tape), sagittal diameter (abdominal caliper) (only week 0 and 16) as wells as fat mass and fat free mass (whole body DXA scan) (only week 0 and 16).	Change from week -4 to week 16
Secondary	Fat disposition and pancreatic fat	Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging	Change from Week 0 to week 16